The European Medicines Agency (EMA) has given the world's first vaccine for malaria the green light, after assessing its safety and effectiveness.
This means that the drug has cleared one of the final hurdles before receiving full approval to be used in Africa.
Later this year, the World Health Organisation (WHO) will consider whether the vaccine - developed by GlaxoSmithKline (GSK) - should be recommended for children, as so far trials among this age group have produced mixed results.
Tested in seven countries across the continent, it was found that the vaccine offered the best protection to children aged between 17 months and five years who received three doses a month apart, plus a booster 20 months later.
The results demonstrated that the most severe cases of malaria were cut by around a third over a period of four years. However, the effectiveness of the vaccine diminished over time, meaning the booster became vital.
According to the study, the jab proved to be ineffective among young babies.
Malaria is caused by the parasite plasmodium, which is passed to humans through a mosquito bite and then multiply in the liver to infect red blood cells. It kills some 584,000 people every year across the globe - many of which are children aged under five in sub-Saharan Africa.
The new vaccine - Mosquirix or RTS,S - is the first of its kind to fight against this parasitic infection in human beings. If successful, the drug will save hundreds of thousands of lives every year.
Commenting on the EMA's decision, Dr Ripley Ballou, head of research at GSK vaccine, said: "This is a hugely significant moment. I've been working on this vaccine for 30 years and this is a dream come true."
While GSK has been tight-lipped on the cost of the vaccine, the firm has made a promise that it will not mark it up to make a profit.
The drug has been specifically designed to battle the infection in children living in Africa, meaning it will not be available to people travelling to the continent.
Now, the WHO faces somewhat of a dilemma, as it must decide in October whether the vaccine should be made available, despite the results not being as positive as GSK researchers had initially hoped.
Professor Adrian Hill, from the Jenner Institute, told the BBC that while the results were promising, the vaccine "was not a magic bullet".
He added: "A bed net is more effective than this vaccine, but nonetheless it is a very significant scientific achievement. I see it as a building block towards much more effective malaria vaccines in years to come."
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